Effects of Vitamin D3 Supplementation on Lung Functions and Exercise Tolerance in D3 Deficient Asthma COPD Overlap (ACO) Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Exercise tolerance measured by level of fatigue
研究概览
简要总结
Vitamin D3 supplementation doen not change lung functions and exercise tolerance in vitamin D3 deficient ACO patient was the null hypothesis of the research.
详细描述
On the first day of enrollment, the objectives, nature, purpose and potential risk of all the procedures used for the study was explained in detail to each ACO patients (diagnosed by pulmonologist), with a cordial attitude giving emphasis on the benefits the participants might obtain from this study. The participants was encouraged for voluntary participation and was allowed to withdraw from the study even after participation, whenever participant felt uneasy. If the participant was agreed to be enrolled in the study, an informed written consent was taken in a prescribed form . Then all the patients were requested to attend the Department of Physiology at 8:30 am (after overnight fasting) on the examination day.
On that day, 10 ml of venous blood was collected from antecubital vein of patient in different vacutainer tubes and was taken to the laboratory of Department of Biochemistry and Molecular Biology as soon as possible, where 3 ml was for the estimation of serum vitamin D3 and rest was preserved at -4˚C.
If the patient was with D3 deficiency [Serum 25(OH)D <30 ng/ml], then the serum creatinine, serum HbA1C, serum parathormone (PTH), serum calcium (Ca2+), serum phosphate (PO43-), serum alkaline phosphatase (ALP), serum glutamate pyruvate transaminase (SGPT) serum cholesterol, serum High Density Lipoprotein (HDL), serum low density lipoprotein (LDL), serum triglyceride (TG), were assessed from the preserved blood. After getting all the biochemical reports the final selection was done, according to the inclusion and exclusion criteria.
Then all the eligible patients were randomly assigned to either 'Study (A)' or 'Control (B)' group.Then all the study variables of all the subjects of both the groups were assessed. These data were recorded as values of 'day 1' (A1, B1).
Subsequently a standard therapeutic treatment [according to Global Initiative for Chronic Obstructive Lung Diseases (GOLD) guideline] were prescribed (by the pulmonologist) to all the selected stable ACO patients of both groups. Proper education were given about drug, method of taking medication and medication plan plan, such as, training for Metered Dose Inhaler (MDI) use for 7 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Pulmonologist diagnosed patient of ACO
- •Vitamin D3 deficient : Serum 25(OH)D <30 ng/ml
- •Age: 40-70 years
- •Sex: Male
- •Socioeconomic status: middle class
- •Anthropometric status:
- •BMI=18.6-24.9 kg mid upper arm circumference>25.1 cm waist-hip ratio<0.89
- •Serum parathormone: 10-65 pg/ml
- •Serum Ca2+: 8.5-10.5 mg/dl
- •Serum PO43: 2.3-4.7 mg/dl
- •Serum alkaline phosphatase: 30-120 U/L
- •SGPT: <50 U/L
- •Serum creatinine: 0.7-1.3 mg/dl
- •Fasting Blood Sugar (FBS): 3.5-6.1 mmol/L
- •Serum HbA1c: 4.5-6.3 %
- •Serum cholesterol: <200 mg/dl
- •Serum HDL: >40 mg/dl,
- •Serum LDL: <130 mg/dl
- •Serum TG: <150 mg/dl
排除标准
- •With history of:
- •any other pulmonary diseases, as, chronic obstructive pulmonary disease bronchial asthma respiratory tract infection bronchiectasis pleural effusion tuberculosis interstitial lung disease pneumonectomy or pulmonary lobectomy
- •any cardiac disease, like - unstable angina pectoris congestive heart failure myocardial infarction cardiac arrhythmia
- •systemic hypertension
- •any liver disease
- •any malignancy
- •use of any drugs known to affect vitamin D metabolism within 1 month prior to study, as, antiepileptics (Phenytoin, Carbamazepine) antibiotics (Clotrimazole, Rifampicin) antihypertensives (Nifedipine, Spironolactone) antiretroviral drugs (Ritonavir, Saquinavir) endocrine drugs (Cyproterone acetate) glucocorticoids bisphosphonate calcium supplement
- •With biochemical evidence of diabetes mellitus renal insufficiency
研究组 & 干预措施
study
Vitamin D.Generic name-Cholecalciferol (40,000 IU).Dose- 80,000. Dosage-2 capsule/week for consecutive 26 weeks
干预措施: Cholecalciferol (Drug)
control
Placebo oral capsule.Dose 80,000.Dosage-2 capsules for consecutive 26 weeks
干预措施: Placebo oral capsule (Other)
结局指标
主要结局
Exercise tolerance measured by level of fatigue
时间窗: 8 month
a subjective, unpleasant symptom which incorporates total body feelings ranging from tiredness to exhaustion, creating an unrelenting overall condition which interferes with individuals' .evaluated by BORG scale.
Lung function status measured by Forced vital capacity (FVC)
时间窗: 8 month
It is the volume of air that can be expired as forcefully and rapidly as possible after maximal inspiration.In adult male it is about 4.6 liters.
Lung function status measured by Forced expiratory volume in 1st second (FEV1) Mid Expiratory Flow 75% (MEF75%),Mid Expiratory Flow50% (MEF50%), Mid Expiratory Flow 25%(MEF25%)
时间窗: 8 month
When a person inspires maximally and exhales forcefully, then the volume, which is exhaled in 1st second is known as 'Forced Expiratory volume in 1st second'. It is normally 80% of forced vital capacity .
Lung function status measured by Ratio of Forced expiratory volume in 1st second and Forced vital capacity (FEV1 /FVC ratio)
时间窗: 8 month
It is the ratio of FEV1 to FVC expressed in percentage. FEV1/FVC ratio = FEV1/FVC×100. It is about 70% or higher.
exercise tolerance measured by Level of dyspnea
时间窗: 8 month
a subjective experience of breathing discomfort that consists of qualitatively distinct sensations that vary in intensity'.evaluated by BORG scale.
Lung function status measured by Peak expiratory flow rate (PEER)
时间窗: 8 month
It is the maximum expiratory rate, beyond which the flow cannot be increased even with greatly increased additional force. In adult it is about 400-700 L/minute.
Forced Expiratory Flow25-75 (MEF25-75)
时间窗: 8 month
Forced expiratory flow during the middle half of the FVC.expressed in liters/second.
exercise tolerance measured by 6 Minute Walk Distancd (6MWD)
时间窗: 8 month
It is the distance that a person can quickly walk on a flat, hard surface in a period of 6 minutes.expressed in meters.
exercise tolerance measured by Oxygen saturation
时间窗: 8 month
Oxygen saturation is defined as the oxygen content expressed as a percentage
次要结局
- Anthropomertric measurement measured by BMI(8 month)
- Anthropomertric measurement measured by mid upper arm circumference (MUAC)(8 month)
- Anthropomertric measurement measured by waist hip ratio(8 month)
研究者
Dr.Naznin Sultana
principal investigator
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh